# K070984: The Precision / Optium Point of Care Blood Glucose Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Diabetes Care, Inc.
- Decided: Nov 1, 2007 after 209 days
- Product code: LFR (Glucose Dehydrogenase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K980731 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021960: Precision Point of Care Blood Glucose Test Strip with True Measure Technology, Abbott Laboratories (2002) Summary page 1.

## Recalls of this device
- Nov 14, 2019 · Class II · Z-1558-2020: Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple
- Dec 22, 2010 · Not classified · Z-0994-2011: Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results.
- Dec 22, 2010 · Not classified · Z-0998-2011: Certain lots of Precision Xtra, Precision Xceed Pro, MediSense Optium, Optium, OptiumEZ and ReliOn Ultima Blood Glucose Test Strips may generate erroneously low blood glucose results.

## Indications for use
The Precision® and Optium® Point of Care Blood Test Strips quantitatively measure glucose (D-glucose) in fresh neonatal, venous, arterial and fingertip capillary whole blood. The test strips are for use outside the body (in vitro diagnostic use) by healthcare professionals for use in healthcare facilities with either the Precision Xtra® or Optium® Blood Glucose Monitoring Systems. Home users may use the system for capillary samples only. The test strips are not for use in diagnosis or screening of diabetes mellitus, but are to be used as an aid in monitoring the effectiveness of diabetes control programs.

Source page: https://510kreport.com/device/K070984
Methodology: https://510kreport.com/methodology